Application of LC–MS/MS Method for Determination of Dihydroartemisin in Human Plasma in a Pharmacokinetic Study

Abstract

Aim: Dihydroartemisinin (DHA) was also found therapeutic potential for the treatment of systemic lupus erythematosus (SLE). To assess the pharmacokinetic profile of DHA, the concentration of DHA in plasma of SLE patients needed be accurately determined based on a rapid and reliable analytical method. Experimental method & results: Developed method utilizes stable isotope-labeled internal standards and SPE method for sample preparation, applied XBridge C18 column (2.1 × 50 mm, 3.5 μm) for chromatography separation. Detection of the analytes was achieved by an AB Sciex 4000 mass spectrometer under positive electrospray ionization mode. The method was validated in accordance with international guidelines on bioanalytical methods validations. Conclusion: DHA concentrations in human plasma of Chinese SLE patients were quantified by developed LC–MS/MS (no. 2016L02562).

Keywords:

• dihydroartemisinin
• human plasma
• LC–MS/MS
• systemic lupus erythematosus

Acknowledgments

The authors thank the subjects enrolled in the study and the staff of the Department of Rheumatology Immunology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital.

Financial & competing interests disclosure

The study was supported by these grants: ‘Chinese National Major Project for New Drug Innovation (2019ZX09734001)’, ‘Drug Development and Application of Chinese Pharmacological Society (No. 2019DL001)’, ‘Jinqiao Project of Beijing Association of Science and Technology (No. ZZ19005)’, ‘Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs (No. 2016-I2M-1-010)’. The authors greatly appreciate KPC Pharmaceuticals, Inc (Kuiming, China) for funding this study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Data sharing statement

Data sharing statement: The authors certify that this manuscript reports original clinical trial data (NMPA; no. 2016L02562). Data from the trial will not be made available.

Additional information

Funding

The study was supported by these grants: ‘Chinese National Major Project for New Drug Innovation (2019ZX09734001)’, ‘Drug Development and Application of Chinese Pharmacological Society (No. 2019DL001)’, ‘Jinqiao Project of Beijing Association of Science and Technology (No. ZZ19005)’, ‘Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs (No. 2016-I2M-1-010)’. The authors greatly appreciate KPC Pharmaceuticals, Inc (Kuiming, China) for funding this study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.